Initiative for Patient Outcomes in Dialysis - Peritoneal Dialysis (PD) (IPOD-PD Study)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Fresenius Medical Care Deutschland GmbH
ClinicalTrials.gov Identifier:
NCT01285726
First received: January 26, 2011
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

The aim of the study is to asses the hydration status of incident peritoneal dialysis (PD) patients and its evolution over a period of four years, independent of the PD treatment modality (APD or CAPD) and the PD solution type.


Condition Intervention
Chronic Renal Failure
Other: Non-interventional study

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Initiative for Patient Outcomes in Dialysis - PD (IPOD-PD Study)

Resource links provided by NLM:


Further study details as provided by Fresenius Medical Care Deutschland GmbH:

Primary Outcome Measures:
  • Hydration status [ Time Frame: Every three months over a period of four years ] [ Designated as safety issue: No ]
    Assessed via body composition measurements (Overhydration, total body water (TBW), extracellular water (ECW), intracellular water (ICW)) (Overhydration, total body water (TBW), extracellular water (ECW), intracellular water (ICW))


Secondary Outcome Measures:
  • Residual renal function [ Time Frame: Every three months over a period of four years ] [ Designated as safety issue: No ]
  • Peritoneal transport status [ Time Frame: Every three months over a period of four years ] [ Designated as safety issue: No ]
  • Time to change to haemodialysis [ Time Frame: Four years ] [ Designated as safety issue: No ]
  • Changes in PD prescription [ Time Frame: Four years ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: January 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ESRD patients treated with PD Other: Non-interventional study
This is a purely non-interventional, observational study, where treatment decisions are completely guided by the discretion of the attending nephrologists.
Other Name: Observational study

Detailed Description:

Achieving optimal fluid balance remains a major clinical challenge in peritoneal dialysis (PD) patients. With the recent development of a new bioimpedance spectroscopy (BIS) device, the BCM-Body Composition Monitor (BCM), it is now possible to quantify deviations of hydration status and to define target weight directly.

It has been observed that more than 50% of the PD patients are overhydrated, as compared to the healthy population. This overhydration seems to be associated with modifiable practice-related factors, such as correct PD prescription according to membrane transport status, and dietary fluid intake.

The aim of this study is to assess the hydration status of incident PD patients, and diagnose the underlying reasons for incorrect fluid status. In addition, changes in fluid status, residual renal function and nutritional status, over a follow-up period of up to four years will be registered.

The investigators assume that the use of the BCM-Body Composition Monitor (BCM) provides quantitative measurement of hydration status and thereby supports physicians in identifying patients who are not euvolaemic. Hence, the BCM allows an improved management of underlying causes of non-euvolaemic hydration state and appropriate monitoring of fluid status.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult patients with chronic kidney disease (CKD) starting renal replacement therapy on APD or CAPD

Criteria

Inclusion Criteria:

  • Incident patients directly before start of peritoneal dialysis
  • Patients in whom routine measurement of body composition monitoring is performed

Exclusion Criteria:

  • Patients treated with HD before start of PD
  • Patients in whom body composition monitoring cannot be performed
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01285726

  Hide Study Locations
Locations
Austria
Klinikum Wels
Wels, Austria
Belgium
ASZ Aalst
Aalst, Belgium
Ghent University Hospital
Gent, Belgium
ASZ Geraardsbergen
Geraardsbergen, Belgium
U.Z. Leuven
Leuven, Belgium
CHU Sart Tilman
Liège, Belgium
Heilig-Hart Roeselare
Roeselare, Belgium
Bosnia and Herzegovina
KBC Mostar
Mostar, Bosnia and Herzegovina
UKC Tuzla
Tuzla, Bosnia and Herzegovina
Brazil
Instituto Mineiro Nefrologia
Belo Horizonte, Brazil
CDR Barra do Piraí
Pirai, Brazil
CETENE
Sao Paolo, Brazil
Croatia
UHC Osijek
Osijek, Croatia
UH Split
Split, Croatia
UH Merkur
Zagreb, Croatia
Cuba
Instituto de Nefrología
La Habana, Cuba
Czech Republic
University Hospital FN Brno Bohunice
Brno, Czech Republic
FN Hradec Kralove
Hradec Kralove, Czech Republic
DS Most
Most, Czech Republic
Faculty Hospital Plzen
Pilsen, Czech Republic
IKEM
Prague, Czech Republic
VFN Strahov
Prague, Czech Republic
Denmark
Herlev Hospital
Herlev, Denmark
Hillerød Hospital
Hillerød, Denmark
Roskilde Hospital
Roskilde, Denmark
Estonia
West Talinn Central Hospital
Tallinn, Estonia
North Estonian Regional Hospital
Tallinn, Estonia
Tartu University Hospital
Tartu, Estonia
Finland
Helsinki University Hospital
Helsinki, Finland
Central Hospital in Joensuu
Joensuu, Finland
Keski-Suomen keskussairaala, Jyväskylä
Jyväskylä, Finland
Kymenlaakson keskussairaala, Kotka
Kotka, Finland
Oulu University Hospital
Oys, Finland
Satakunnan keskussairaala, Pori
Pori, Finland
Tampere University Hospital
Tampere, Finland
France
CHU de Bordeaux
Bordeaux, France
C.H. Dunkerque
Dunkerque, France
Hôpital Bichat - Claude Bernard
Paris, France
Centre Hospitalier René Dubos
Pontoise, France
AUB Quimper / Centre Hospitalier Laennec
Quimper, France
ECHO Confluent
Rezé, France
Hôpital Civil de Strasbourg
Strasbourg, France
Germany
KfH Nierenzentrum Bottrop
Bottrop, Germany
Klinikum Braunschweig
Braunschweig, Germany
Nierenzentrum Heidelberg
Heidelberg, Germany
Nieren und Hochdruckzentrum Kiel
Kiel, Germany
Robert Bosch Krankenhaus
Stuttgart, Germany
Nephrologisches Zentrum Velbert Innere Medizin und Nephrologie
Velbert, Germany
Nephrologische Praxis Wiesbaden
Wiesbaden, Germany
Greece
General University Hospital of Alexandroupolis
Alexandroupolis, Greece
General Hospital of Athens G. Gennimatas
Athens, Greece
General Hospital of Ioannina
Ioannina, Greece
General University Hospital of Ioannina
Ioannina, Greece
General University Hospital of Thessaloniki "AHEPA"
Thessaloniki, Greece
India
MMM - Chennai
Chennai, India
Israel
Western Galilee Hospital
Nahariyya, Israel
Italy
UO Nefrologia Policlinico BARI
Bari, Italy
Azienda Ospedaliera Brotzu
Cagliari, Italy
Ospedale Civico Palermo
Palermo, Italy
Ospedale San Bartolo
Vicenza, Italy
Korea, Republic of
Yeungnam University Hospital
Daegu, Korea, Republic of
NHIC Ilsan Hospital
Goyang, Korea, Republic of
Konkuk University Medical Center
Seoul, Korea, Republic of
Seoul National University Hospitall
Seoul, Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of
Latvia
P. Stradins hospital
Riga, Latvia
Med Alfa Ltda
Riga, Latvia
Lithuania
Kaunas clinics
Kaunas, Lithuania
Klaipeda Republic Hospital
Klaipeda, Lithuania
Vilnius Univ. Antakalnio Hospital
Vilnius, Lithuania
Netherlands
University Hospital Maastricht
Maastricht, Netherlands
Norway
Sykehuset i Møre og Romsdal HF
Aalesund, Norway
Nordlandssykehuset Bodø
Bodø, Norway
Sykehuset Levanger
Levanger, Norway
St. Olavs Hospital
Sluppen, Norway
Portugal
Hospital Santa Cruz
Carnaxide, Portugal
CHP Hospital Santo Antonio
Porto, Portugal
Spain
Hospital Universitario A Coruñ
A Coruña, Spain
CHU Albacete
Albacete, Spain
Hosp. Univ. Fundacion Alcorcon
Alcorcon, Spain
Hospital De Torrecardenas
Almeria, Spain
Fundació Puigvert
Barcelona, Spain
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital de Basurto
Bilbao, Spain
Hospital de Galdakano
Bilbao, Spain
Hospital General de Castellón
Castellón, Spain
Hospital Univ. Puerta del Mar
Cádiz, Spain
Hospital Josep Trueta
Girona, Spain
Complejo Hospitalario de Jaén
Jaén, Spain
CAULE
León, Spain
Hospital San Pedro
Logroño, Spain
Hospital Lucus Augusti
Lugo, Spain
Hospital Universitario Puerta
Madrid, Spain
Hospital Clinico San Carlos
Madrid, Spain
HGU Gregorio Marañon
Madrid, Spain
Hospital Univ. Ramón y Cajal
Madrid, Spain
Fundación Jiménez Díaz
Madrid, Spain
Hospital Severo Ochoa
Madrid, Spain
Hospital Carlos Haya
Malaga, Spain
Fundación Hospital Manacor
Manacor, Spain
Hospital de Mollet
Mollet del Valles, Spain
Hospital Universitario Central
Oviedo, Spain
Hospital Univ. de Puerto Real
Puerto Real, Spain
HUM Valdecilla
Santander, Spain
CHUS
Santiago de Compostela, Spain
Hospital Virgen de la Macarena
Sevilla, Spain
Hospital Clínico de Valencia
Valencia, Spain
Hospital Rio Hortega
Valladolid, Spain
Hospital general de Vic
Vic, Spain
CHU Xeral Cies Vigo
Vigo, Spain
Hospital Txagorritxu
Vitoria, Spain
Sweden
Mälarsjukhuset Eskilstuna
Eskilstuna, Sweden
Sahlgrenska PD-mottagningen
Göteborg, Sweden
Hallands Hospital Halmstad
Halmstad, Sweden
Sunderby Sjukhus
Luleå, Sweden
Skånes Universitetssjukhus Malmo
Malmo, Sweden
Kungsholmsdialysen
Stockholm, Sweden
Karolinska Univers. Hospital
Stockholm, Sweden
Danderyds Hospital
Stockholm, Sweden
Switzerland
Luzern Kantonsspital
Luzern, Switzerland
Turkey
Akdeniz Universitesi
Antalya, Turkey
United Kingdom
Ninewells Hospital, Renal Unit
Dundee, United Kingdom
Western Infirmary Glasgow
Glasgow, United Kingdom
Royal London Hospital
London, United Kingdom
Norfolk & Norwich Hospital
Norwich, United Kingdom
Venezuela
FME Caracas
Caracas, Venezuela
FME Charallave
Charallave, Venezuela
Cenesuca (FME Cumana)
Cumana, Venezuela
FMC El tigre Edo Anzoátegui
El Tigre, Venezuela
FME Zulia
Maracaibo, Venezuela
FME Maturin
Maturin, Venezuela
FME Puerto de la Cruz
Puerto La Cruz, Venezuela
FME Maracay
Turmero, Venezuela
Instituto Docente de Urologia
Valencia, Venezuela
Nefrologico Valencia sur
Valencia, Venezuela
Sponsors and Collaborators
Fresenius Medical Care Deutschland GmbH
Investigators
Study Chair: Claudio Ronco, Prof Ospedale San Bartolo
Study Chair: Wim Van Biesen, Prof Ghent University Hospital
Study Chair: Christian Verger, Dr Centre Hospitalier René Dubos
Study Chair: John Williams, Prof University Hospital of Wales
  More Information

No publications provided

Responsible Party: Fresenius Medical Care Deutschland GmbH
ClinicalTrials.gov Identifier: NCT01285726     History of Changes
Other Study ID Numbers: BCM-PD-02-INT
Study First Received: January 26, 2011
Last Updated: August 13, 2013
Health Authority: Belgium: Ethics Committee
Bosnia: Federal Ministry of Health
Croatia: Ethics Committee
Finland: Ethics Committee
Estonia: Research Ethics Committee
Germany: Ethics Commission
Greece: Ethics Committee
Italy: Ethics Committee
Latvia: Institutional Review Board
Lithuania: Bioethics Committee
Netherlands: Independent Ethics Committee
Norway: Ethics Committee
Portugal: Health Ethic Committee
Spain: Comité Ético de Investigación Clínica
Sweden: Institutional Review Board
Switzerland: Ethikkommission
Turkey: Ethics Committee
Brazil: Ethics Committee
Cuba: Scientific and Ethics Committee
Venezuela: Ethics Committee
Korea: Institutional Review Board
India: Institutional Review Board

Keywords provided by Fresenius Medical Care Deutschland GmbH:
Peritoneal dialysis
Hydration status
Residual renal function
Bioimpedance spectroscopy
Body composition monitor

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases

ClinicalTrials.gov processed this record on October 23, 2014